Article History
Received: 4 March 2021
Accepted: 4 November 2021
First Online: 27 November 2021
Declarations
:
: This trial will not study or collect identifiable data on any human subjects. All donors enrolled in this study have been declared dead by neurologic criteria. However, this donor management study will be approved by the research/ethics committees at each participating OPO site. The study first received determination of non-human subjects’ status from the <i>Human Research Protection Office</i> (HRPO) at Washington University in St. Louis (the academic affiliation of the PI). The individual OPOs will not be collecting data on recipients and so will not be engaged in human subjects’ research. However, recipient outcome is a key safety endpoint for this study. The central study coordinators will use the UNOS IDs to obtain de-identified recipient outcome data through UNOS/SRTR. As the recipients’ are human subjects, in order to collect recipient outcome data, we have obtained a waiver of recipient consent from the HRPO at the coordinating site. The collection of de-identified recipient outcomes, as outlined, does not pose more than minimal risk to their privacy or safety. The study will not influence how hearts are allocated to particular recipients or means of allocation. Recipient consent would not be feasible at the time of study randomization as this occurs before heart allocation has begun, when the status of the heart and the identity of the recipient are unknown. The study intervention (T4, a standard practice in donor management) will be disclosed as part of the DonorNet platform that transplant centers/surgeons review. Although we do not mandate that information on the study and intervention be directly disclosed to those individuals ultimately receiving the donor hearts, this can be provided to recipients at their discretion. Furthermore, the use of T4 (or not) is not routinely disclosed in standard practice and so this was not felt to be a significant barrier to their autonomy and decision-making. Furthermore, we will monitor for any negative impact on recipients (as a group) through our interim analysis (as overseen by the DSMC) and halt the study if one group exhibits fewer hearts transplanted or worse graft outcomes.
: Not applicable.
: RD is a consultant for Mid-America Transplant but did not receive any support for any aspect of the study. GM is an employee of Mid-America Transplant. DK is a consultant for Mid-America Transplant, the sponsor of this study. The other authors have no competing interests.